Label: PHARBEST ASPIRIN 325MG- aspirin tablet, delayed release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 22, 2017

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient (in each tablet)

    Aspirin 325mg (NSAID)*

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever

  • Uses

    • temporarily relieves minor aches and pains due to • colds • headache • muscle pain • menstrual pain • minor pains of arthritis • toothache
    • or as receommended by your doctor
  • Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.


    Allergy alert: Aspirin may cause a severe allergic reaction which may include

    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you

    • are age 60 or older
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • take more or for a longer time than directed
    • have had stomach ulcers or bleeding problems
    • have 3 or more alcoholic drinks every day while using this product

    Do not use

    if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer.

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you are taking a diuretic
    • you have asthma
    • you have high blood pressure, heart disease, liver cirrhosis or kidney disease

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for

    • gout
    • diabetes
    • arthritis

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding •feel faint • vomit blood • have bloody or black stools
    • have stomach pain that does not get better
    • pain gets worse or lasts more than 10 days
    • redness or swelling is present
    • any new symptoms occur
    • ringing in the ears or loss of hearing occurs

    These could be signs of a serious condition.

    If pregnant or breast-feeding

    ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • drink a full glass of water with each dose
     adults and children 12 years and over take 1 to 2 tablets every 4 hours while symptoms persist. Do not exceed 12 tablets in 24 hours unless diretced by a physician. 
     children under 12 years consult a physician

  • Other information

    • avoid excess heat and moisture
    • store below 25 0 C (77 0 F)
  • Inactive ingredients

    croscarmellose sodium, D&C yellow #10 Lake, FD&C red #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin. 

  • Questions or comments?

    Adverse drug event call: 1-866-562-2756 

  • PRINCIPAL DISPLAY PANEL

    Manufactured in the U.S.A

    PHARBEST

    Aspirin Regimen 

    †Compare to the active ingredient in Ecotrin ® Regular Strength

    #1 Choise of Cardiologists

    Aspirin 325mg

    Regular Strength

    Safety Coated Aspirin 325mg

    PAIN RELIEVER (NSAID)

    NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

    image of label

  • INGREDIENTS AND APPEARANCE
    PHARBEST ASPIRIN 325MG 
    aspirin tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-169(NDC:16103-357)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code PH024
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67046-169-077 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/2017
    2NDC:67046-169-1414 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/2017
    3NDC:67046-169-1515 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/2017
    4NDC:67046-169-2020 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/2017
    5NDC:67046-169-2121 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/2017
    6NDC:67046-169-2828 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/2017
    7NDC:67046-169-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/2017
    8NDC:67046-169-6060 in 1 BLISTER PACK; Type 0: Not a Combination Product09/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34309/22/2017
    Labeler - Contract Pharmacy Services-PA (945429777)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coupler Enterprises945429777repack(67046-169)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!